Senior Manager Medical Writing

hace 3 semanas

Barcelona, España Alexion Pharmaceuticals,Inc. A tiempo completo

Location: Barcelona, Spain

Job reference: R-199878

Date posted: 05/16/2024

**This is what you will do**:
This position is accountable for the timely preparation of high quality, regulatory-compliant clinical document deliverables for Alexion. This position will support the medical writing (MW) activities for one or more clinical programs. This position will function with moderate supervision.

**You will be responsible for**:

- Supporting clinical project teams by authoring and managing the development and completion of high-quality clinical regulatory documents including, but not limited to, clinical study protocols and amendments, clinical study reports, Investigator's Brochures and updates, and clinical Common Technical Document components (eg, Module 2 summaries).
- Ensuring strategic organization, clarity, accuracy, format, and consistency of scientific content.
- Representing MW cross-functionally and with external vendors, negotiating timelines as necessary.
- Participating with other MW team members to develop and implement process and standards, and take responsibility for execution in cross-functional teams.
- Maintaining adherence to internal guidelines, styles, processes, standard operating procedures, and regulatory requirements in partnership with colleagues from statistical, clinical, regulatory, quality, and patient safety functions.
- Developing effective collaborations with other functional lines within Alexion, and keeping abreast of regulatory, industry, and medical writing knowledge and best practices.

**You will need to have**:

- 3-5 years of regulatory writing experience; will consider fewer years of writing experience combined with other relevant experience.
- Demonstrated capability to understand and summarize complex clinical data, and write and manage clinical study documents (eg, clinical study protocols, clinical study reports, and Investigator's Brochures).
- Knowledge of global regulatory requirements and ICH/GCP guidelines.
- Excellent oral, written, and presentation skills; advanced user of MS Office suite.
- Results
- and compliance-driven; sets standard of excellence for self and others.
- The duties of this role are generally conducted in an office environment. As is typical of an office-based role, employees must be able, with or without an accommodation to use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and non-linear thought, analysis, and dialogue; collaborate with others; and maintain general availability during standard business hours.

**We would prefer for you to have**:

- MS or PhD degree in a relevant scientific/clinical/regulatory field.
- Ability to establish excellent internal and external relationships, including alliance partners and vendors.
- Team player who thrives in a team-based environment.
- Well-developed sense of ethics, responsibility, and respect for others.
- Agile learner with ability to work both collaboratively and independently, seeking advice as required.

High level of flexibility and ability to innovate and

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